Choice 2 Try-In Paste 4 Syringes Kit C-39011K

GUDID 00810111542982

Choice 2 Try-In Paste 4 Syringes (1 each (2g): A1, B1, Milky Bright, Translucent)

BISCO INC.

Dental cement trial

• Primary Device ID: 00810111542982
• NIH Device Record Key: 58639c82-2dc1-4bcc-a76b-62d71126f412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Choice 2 Try-In Paste 4 Syringes Kit
• Version Model Number: C-39011K
• Catalog Number: C-39011K
• Company DUNS: 053529939
• Company Name: BISCO INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111542982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993192

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

Devices Manufactured by BISCO INC.

• 00810111542982 - Choice 2 Try-In Paste 4 Syringes Kit: 2025-06-06Choice 2 Try-In Paste 4 Syringes (1 each (2g): A1, B1, Milky Bright, Translucent)
• 00810111542982 - Choice 2 Try-In Paste 4 Syringes Kit: 2025-06-06 Choice 2 Try-In Paste 4 Syringes (1 each (2g): A1, B1, Milky Bright, Translucent)
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• D757B36050P1 - Ace All-Bond TE 4 Cartrdg Pkg: 2024-02-16
• D757B3605PS1 - ACE-All-Bond TE 1 CartridgePkg: 2024-02-16
• D757B36100K1 - ACE All-Bond TE Starter Kit: 2024-02-16